CABREN 2.5 MG PROLONGED RELEASE TABLETS

Transcript

Package leaflet: Information for the patient
CABREN 2.5 mg, 5 mg and 10 mg prolonged-release tablets
Felodipine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Cabren is and what it is used for
2. What you need to know before you take Cabren
3. How to take Cabren
4. Possible side effects
5. How to store Cabren
6. Contents of the pack and other information
1. What Cabren is and what it is used for
Cabren contains the active substance felodipine. This belongs to a group of medicinces called
calcium antagonists. It lowers blood pressure by dilating small blood vessels. It does not negatively
affect the heart function.
Cabren is used in the treatment of high blood pressure (hypertension) and heart and chest pain
brought on by for example exercise or stress (angina pectoris).
2. What you need to know before you take Cabren
Do not take Cabren
- if you are pregnant. You should tell your doctor as soon as possible if you become pregnant while
using this medicine.
- if you are allergic to felodipine or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from decompensated heart failure.
- if you have acute myocardial infarction (heart attack).
- if you have chest pain of recent onset, or angina pectoris that is lasting for more than 15 minutes or
longer or is more severe than usual.
- if you have disease of a heart valve or heart muscle, until you have talked to your doctor.
Warnings and precautions
Cabren, like other blood-pressure lowering medicinal products, may in rare cases lead to
pronounced low blood pressure which in some patients may result in an inadequate supply of blood
to the heart. Symptoms of excessive low blood pressure and inadequate blood supply to the heart
itself, frequently include dizziness and chest pain. If you experience these symptoms, seek
emergency care immediately.

Talk to your doctor before taking Cabren, especially if you have problems with your liver.
Taking Cabren may cause your gums to become swollen. Practice good oral hygiene to help avoid
your gums from swelling (see section 4).
Children
The use of Cabren is not recommended in children.
Other medicines and Cabren
Tell your doctor if you are taking, have recently taken or might take any other medicines. Some
medicines/herbal remedies can affect treatment with Cabren.
Examples are:
• cimetidine (medicine to treat gastric ulcers)
• erythromycin (medicine to treat infections)
• itraconazole (medicine to treat fungi)
• ketoconazole (medicine to treat fungi)
• medicines to treat HIV protease inhibitors (such as ritonavir)
• medicines to treat HIV infection (such as efavirenz, nevirapine)
• phenytoin (medicine to treat epilepsy)
• carbamazepine (medicine to treat epilepsy)
• rifampicin (medicine to treat infections)
• barbiturates (medicine to treat anxiety, sleeping problems and epilepsy)
• tacrolimus (medicine used in organ transplantations)
Medicines containing St John’s wort (Hypericum perforatum) (herbal product used to treat
depression) may reduce the effect of Cabren and should therefore be avoided.
Cabren with food and drink
Do not drink grapefruit juice if you are treated with Cabren, as this may increase the effect of
Cabren and the risk of side effects.
Pregnancy and breast-feeding
Pregnancy
Do not use Cabren if you are pregnant.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Cabren is not
recommended for mothers who are breast-feeding, and your doctor may choose another treatment
for you if you wish to breast-feed.
Driving and using machines
Cabren can have minor or moderate influence on your ability to drive and use machines. If you
experience headache, nausea, dizziness or fatigue your ability to react may be impaired. Caution is
recommended especially at the start of treatment.
Cabren contains lactose
Cabren contains lactose that is a type of sugar. If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Cabren

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are
not sure. Cabren extended release tablets should be taken in the morning and be swallowed with
water. The tablet must not be divided, crushed or chewed. This medicine can be taken without food
or following a light meal not high in fat or carbohydrates.
Hypertension
Treatment should be started with 5 mg once a day. If necessary, your doctor may increase the dose
or add another blood-pressure lowering medicine. The usual dose when treating this disease for a
long time is 5-10 mg once a day. In elderly patients, a starting dose of 2.5 mg daily may be
considered.
Stable angina pectoris
Treatment should be started with 5 mg once a day and if needed, your doctor may increase the dose
to 10 mg once a day.
If you have liver problems
The level of felodipine in your blood may be increased. Your doctor may lower the dose.
Elderly people
Your doctor may initiate treatment with the lowest available dose.
If you take more Cabren than you should
If you take more than the recommended number of doses of Cabren, you may suffer from very low
blood pressure and sometimes palpitations, high or, rarely, slow heart rate. Therefore, it is very
important that you take the number of doses prescribed by your doctor. If you experience symptoms
such as feeling faint, light-headedness or dizziness, contact your doctor immediately.
If you forget to take Cabren
If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Cabren
If you stop taking this medicine your condition may return. Please consult your doctor and seek
advice before you stop taking Cabren. Your doctor will advise you how long to take your medicine.
If you have any further questions on the use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen to you, stop taking Cabren and tell a doctor straight away:
• Hypersensitivity and allergic reactions: The signs may include raised lumps on your skin (weals)
or swelling of your face, lips, mouth, tongue or throat.
The following undesirable effects have been identified. Most of these reactions appear at start of
treatment or after a dose increase. Should such reactions occur, they are usually brief and diminish
in intensity with time. If you experience any of the following symptoms and they persist, please tell
your doctor.
Mild enlargement of the gums has been reported in patients with an inflammation in the mouth
(gingivitis/periodontitis). The enlargement can be avoided or reversed by careful oral hygiene.

Very common: may affect more than 1 in 10 people
• Ankle swelling
Common: may affect up to 1 in 10 people
• Headache
• Flushing
Uncommon: may affect up to 1 in 100 people
• Abnormally rapid heart rate
• Palpitations
• Too low blood pressure (hypotension)
• Nausea
• Abdominal pain
• Burning/prickling/numbness
• Rash or itching
• Fatigue
• Dizziness
Rare: may affect up to 1 in 1,000 people
• Fainting
• Vomiting
• Nettle rash
• Pain in joints
• Muscular pain
• Impotence/sexual dysfunction
Very rare: may affect up to 1 in 10,000 people
• Gingivitis (swollen gums)
• Increased liver enzymes
• Skin reactions due to increased sensitivity to sunlight
• Inflammation of small blood vessels of the skin
• A need to pass water frequently
• Hypersensitivity reactions such as fever or swelling of the lips and tongue
Other undesirable effects may occur. If you have any bothersome or unusual reaction while taking
Cabren, check with your doctor right away.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Cabren
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle after
‘EXP’. The expiry date refers to the last day of that month.
Do not use this medicine if you notice the packaging is torn or damaged.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.